ACTIVE_NOT_RECRUITING

Conventional or Hypofractionated Radiation Therapy in Treating Patients With Prostate Cancer

Conditions

Stage I Prostate Cancer AJCC v8 Stage II Prostate Cancer AJCC v8 Stage III Prostate Cancer AJCC v8 Stage IVA Prostate Cancer AJCC v8

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This phase III trial studies how well hypofractionated radiation therapy works compared to the conventional one in treating patients with prostate cancer. Radiation therapy uses high energy beams to kill tumor cells and shrink tumors. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects.

Official Title

Post Operative External Beam Radiotherapy for Prostate Cancer: Randomized Trial Comparing Standard vs. Hypofractionated Radiation Therapy (PORT-HYFX)

Quick Facts

Study Start:2019-05-30

Study Completion:2025-11-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT03987386

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Men age 18 or older * Patient has diagnosis of pathologically confirmed prostate cancer, treated with radical prostatectomy. Any type of radical prostatectomy will be permitted, including retropubic, perineal, laparoscopic, or robotically assisted * Patient has pathologic T2-T3M0 stage. Patients can have 5 or less metastatic pelvic lymph nodes confirmed by pathology * For patients radiated in the post-operative salvage setting: pathology can demonstrate any of the following features but not required, positive margin, extracapsular extension, or seminal vesicle involvement with detectable prostate-specific antigen (PSA) of \>= 0.1. PSA \>= 0.1 after radical prostatectomy: most recent PSA value within 12 months of registration and prior to initiating any androgen deprivation therapy (ADT) * Patient diagnosed with Gleason score of 6-10 * Eastern Cooperative Oncology Group (ECOG) performance 0-2 * Patients may receive 6 months and up to 24 months of androgen deprivation therapy. Patients may have received androgen deprivation therapy up to 12 months prior to postoperative radiotherapy * If the patient has a prior history of any cancer other than prostate cancer, he must have completed treatment within 1 year of study registration and the patient must have no evidence of disease of this prior non-prostate cancer	* Prior radiation therapy to prostate/seminal vesicle fossa or postoperative region * Neoadjuvant chemotherapy before or after prostatectomy * History of lupus, scleroderma, or calcinosis, Raynaud's phenomenon, esophageal dysmotility, sclerodactyly, and telangiectasia (CREST) syndrome * History of severe active co-morbidity or uncontrolled diabetes * Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months * Transmural myocardial infarction within the last 6 months * Severe hepatic disease, defined as a diagnosis of Child-Pugh class B or C hepatic disease * End-stage renal disease (i.e., on dialysis or dialysis has been recommended)

Inclusion Criteria

Exclusion Criteria

* Men age 18 or older
* Patient has diagnosis of pathologically confirmed prostate cancer, treated with radical prostatectomy. Any type of radical prostatectomy will be permitted, including retropubic, perineal, laparoscopic, or robotically assisted
* Patient has pathologic T2-T3M0 stage. Patients can have 5 or less metastatic pelvic lymph nodes confirmed by pathology
* For patients radiated in the post-operative salvage setting: pathology can demonstrate any of the following features but not required, positive margin, extracapsular extension, or seminal vesicle involvement with detectable prostate-specific antigen (PSA) of \>= 0.1. PSA \>= 0.1 after radical prostatectomy: most recent PSA value within 12 months of registration and prior to initiating any androgen deprivation therapy (ADT)
* Patient diagnosed with Gleason score of 6-10
* Eastern Cooperative Oncology Group (ECOG) performance 0-2
* Patients may receive 6 months and up to 24 months of androgen deprivation therapy. Patients may have received androgen deprivation therapy up to 12 months prior to postoperative radiotherapy
* If the patient has a prior history of any cancer other than prostate cancer, he must have completed treatment within 1 year of study registration and the patient must have no evidence of disease of this prior non-prostate cancer

* Prior radiation therapy to prostate/seminal vesicle fossa or postoperative region
* Neoadjuvant chemotherapy before or after prostatectomy
* History of lupus, scleroderma, or calcinosis, Raynaud's phenomenon, esophageal dysmotility, sclerodactyly, and telangiectasia (CREST) syndrome
* History of severe active co-morbidity or uncontrolled diabetes
* Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
* Transmural myocardial infarction within the last 6 months
* Severe hepatic disease, defined as a diagnosis of Child-Pugh class B or C hepatic disease
* End-stage renal disease (i.e., on dialysis or dialysis has been recommended)

Contacts and Locations

Principal Investigator

Quynh-Nhu Nguyen

PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Study Locations (Sites)

M D Anderson Cancer Center

Houston, Texas, 77030

United States

MD Anderson League City

League City, Texas, 77573

United States

MD Anderson in Sugar Land

Sugar Land, Texas, 77478

United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

Quynh-Nhu Nguyen, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-05-30

Study Completion Date2025-11-01

Study Record Updates

Study Start Date2019-05-30

Study Completion Date2025-11-01

Terms related to this study

Additional Relevant MeSH Terms

Stage I Prostate Cancer AJCC v8
Stage II Prostate Cancer AJCC v8
Stage III Prostate Cancer AJCC v8
Stage IVA Prostate Cancer AJCC v8